IMPRESSIX by CAVEX HOLLAND B.V. | FDA 510(k) Summary

ImprEssix alginate impression material is a dental impression material based on alginate. It is used for taking impressions of the oral cavity with the purpose of constructing a gypsum cast that is a copy of the situation in the mouth. ImprEssix has an extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum and is presented in a attractive fuchsia-coloured powder with a red-fruit flavour. Therefore, ImprEssix is particularly suited for orthodontics

Device Description

AI/ML Overview

The provided text is an FDA 510(k) clearance letter for a medical device called "ImprEssix Alginate Impression Material." This letter is a regulatory document and does not contain information about acceptance criteria or a study proving the device meets those criteria.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring extensive clinical trials to establish new performance metrics. Therefore, the detailed information requested in your prompt (acceptance criteria, specific study designs, sample sizes, expert qualifications, etc.) is typically not part of this type of regulatory document.

To directly answer your prompt based on the provided text, I must state that the information is not available within the document.

Here's a breakdown of why each specific point cannot be addressed from the given text:

A table of acceptance criteria and the reported device performance: Not present. The letter mentions characteristics like "extra fast setting time, high elasticity, high tear resistance, can be poured twice with gypsum," but these are descriptive features, not quantitative acceptance criteria with reported performance data from a study.
Sample size used for the test set and the data provenance: Not present. No study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present. No study details are provided.
Adjudication method for the test set: Not present. No study details are provided.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is an alginate impression material, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an alginate impression material, not an algorithm.
The type of ground truth used: Not present. No study details are provided.
The sample size for the training set: Not applicable. This device is an alginate impression material, not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable. This device is an alginate impression material, not a machine learning modelrequiring a training set.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

NOV 2 3 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Woortman Manager Technical Services Cavex Holland B.V. Harmenjansweg 21 Haarlem, 2031WH NETHERLANDS

Re: K052455

Trade/Device Name: ImprEssix Alginate Impression Material Regulation Number: 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: August 15, 2005 Received: September 7, 2005

Dear Mr. Woortman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Woortman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) NUMBER (IF KNOWN): KO 52455

DEVICE NAME: ImprEssix

Alginate impression material

INDICATIONS FOR USE:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED. )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use -(Per 21 CFR 801.109) OR

Over-The-Counter-Use (Optional Format 1-2-96)

Susan Rumm

ා 3 (Sign-Off) of Anesthesiology, General Hospital, tion Control, Dental

Number. RO

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).